US Clinical Trial NCT03965702

Manual Versus Assisted Fluid Management in Surgical Patients: A Randomized Controlled Trial  May 24, 2019

Many trials have indicated that goal-directed fluid therapy (GDFT) strategies may benefit high-risk surgical patients but these strategies are infrequently implemented. It has also been shown that without any goal or protocol for fluid resuscitation, large inter- and intra-provider variability exist and have been correlated with marked variations in patient outcomes. Even under ideal study conditions, strict adherence to GDFT protocols is hampered by the workload and concentration required for consistent implementation.Haemodynamic monitors and protocols alone do not enable optimal fluid titration to be provided consistently to all patients - there must also be appropriate and timely interpretation and intervention.

To address this problem of consistency and protocol adherence, a clinical decision support system, "Assisted Fluid Management" (AFM), has been designed to help ease some of the workload associated with GDFT protocol implementation. The AFM system (released on the European market in March 2017) may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This system can suggest fluid bolus administration, analyse the effects of the bolus, and continually re-assess the patient for further fluid requirements.

A recent published study demonstrated that the implementation of the AFM for GDFT guidance resulted in a significantly longer period during surgery with a SVV <13% with a reduced total amount of fluid administered without any difference in postoperative complications.

Another recent study demonstrated that during abdominal surgery, microvascular perfusion is impaired during preload dependence (SVV >13%) and recovers after fluid administration.

Therefore the goal of this randomized controlled trial is to compare a manual GDFT approach ( standard of care actually in the department) versus an Assisted fluid management approach (using the AFM mode) on the Microvascular flow index.

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AFM Monitoring

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Source:  NIH Last updated:  Jun 12, 2019

From ClinicalTrials.gov, a database of the U.S. National Institutes of Health, through its National Library of Medicine. This record may not reflect the most current and accurate biomedical/scientific data available from the NLM/NIH.